WO2017001795A1 - Needleless injector with a compression spring - Google Patents

Needleless injector with a compression spring Download PDF

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Publication number
WO2017001795A1
WO2017001795A1 PCT/FR2016/051656 FR2016051656W WO2017001795A1 WO 2017001795 A1 WO2017001795 A1 WO 2017001795A1 FR 2016051656 W FR2016051656 W FR 2016051656W WO 2017001795 A1 WO2017001795 A1 WO 2017001795A1
Authority
WO
WIPO (PCT)
Prior art keywords
injection
spring
compression spring
cover
axis
Prior art date
Application number
PCT/FR2016/051656
Other languages
French (fr)
Inventor
Gilles VIVIEN
Jean Christophe CLOIX
Original Assignee
Crossject
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Crossject filed Critical Crossject
Priority to EP16742361.5A priority Critical patent/EP3316932B1/en
Priority to ES16742361T priority patent/ES2735424T3/en
Publication of WO2017001795A1 publication Critical patent/WO2017001795A1/en
Priority to US15/848,043 priority patent/US20180110929A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/30—Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
    • A61M5/3007—Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules with specially designed jet passages at the injector's distal end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2033—Spring-loaded one-shot injectors with or without automatic needle insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/30—Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2006—Having specific accessories
    • A61M2005/2013—Having specific accessories triggering of discharging means by contact of injector with patient body

Definitions

  • the invention relates to a needleless injection device which is equipped with a compression spring.
  • the technical field of the invention is that of needle-free injection devices, pre-filled and disposable, operating with a source of energy such as a gas generator, and used for intradermal, subcutaneous and intramuscular injections. , of liquid active ingredient for therapeutic use in human or veterinary medicine.
  • the active ingredient consists of a more or less viscous liquid, a mixture of liquid, or a gel.
  • the active ingredient may also be a solid dissolved in a solvent suitable for injection or consist of a powdery solid suspended at a certain concentration in a suitable liquid. The granulometry of the active ingredient must then be compatible with the diameter of the ducts to avoid closing them.
  • An injection device comprises in known manner, as for example in the patent application FR-A-2815544 (equivalent to WO 02/34317), a body successively comprising a gas generator, an expansion chamber, a reservoir containing the liquid active ingredient and an injection system.
  • the reservoir is constituted by a glass tube which is inserted into a tubular housing delimited by the body of the device, and which is closed off by an upstream piston and a downstream piston between which is contained the liquid active principle.
  • the free end downstream, or lower, of the reservoir cooperates with an injection nozzle which defines at least one injection channel extending axially along an injection axis.
  • the injection nozzle is delimited axially by an upper face bearing axially on the reservoir, and a lower injection face adapted to cooperate with a closure cap.
  • the injection device comprises a hollow cap which envelops the body and which delimits a lower opening adapted for the passage of the injection nozzle.
  • the body is slidably mounted in the hood, from bottom to top along a sliding axis, between a rest position and an injection position, the driving of the body being performed when the user presses the injection nozzle on his skin.
  • the movement of the body in the hood allows the triggering of the gas generator, generating a pressurized gas which drives the pistons in motion to inject the active ingredient through the skin of the user, through the injection nozzle.
  • a helical compression spring is interposed axially, along the axis of sliding, between the body and the cover, to compress the skin tissue of the user during the application of the nozzle on the skin.
  • the percussion device is triggered when the body reaches its injection position.
  • the user must press the hood of the injection device, to slide the cover relative to the body of the device according to a determined release stroke.
  • the tripping stroke is given by the sum of the spaces between the turns of the spring. To increase this race you have to increase this space and therefore increase the total height of the device.
  • an injection system comprising at least one piston, a reservoir of active principle, an injection nozzle delimiting at least one injection channel,
  • a body which is enveloped by the hood and which is slidably mounted relative to the hood, from bottom to top along an injection axis, between a rest position and an injection position,
  • a compression spring which is interposed axially, along the axis of injection, between the body and the cover, to compress the tissues of the skin of the user during the application of the nozzle to the skin,
  • the compression spring is a frustoconical helical spring which extends along the injection axis, and which comprises a plurality of turns designed to interlock axially into each other.
  • the compression spring according to the invention makes it possible to reduce the vertical space between the body and the internal face of the cover to a coil thickness of the spring, when the body occupies its triggering position.
  • the compression spring makes it possible to vary the setting of the spring by acting on the section of the wire forming the turns, without substantially reducing the release path of the body.
  • the spring due to its frustoconical shape and its turns which fit together without axial play, the addition of turns does not impact the trigger stroke of the body.
  • the turns of the spring are not in contact with each other during the sliding of the body, so that the spring does not emit friction noise.
  • the compression spring extends axially from a high turn which is supported on the hood, to a low turn which bears on the body, the high turn having a diameter greater than the diameter of the low spire.
  • the larger diameter of the upper turn of the spring allows better stability of the spring.
  • the cap delimits a housing which receives the high turn of the spring, to lock in translation the high turn laterally.
  • This feature also allows for better stability of the spring.
  • the body forms a boss that protrudes vertically upward along the injection axis, the lower coil of the spring being mounted around the boss, so that the low turn is blocked laterally.
  • the compression spring is calibrated so that the force required to drive the body from its rest position to its trigger position is between five and forty five Newtons.
  • the active ingredient contained in the reservoir is chosen from the group comprising the following active ingredients:
  • FIG. 1 is an axially exploded perspective view, which illustrates a needleless injection device according to the invention
  • FIG. 2 is a simplified cross-sectional view, which illustrates the body of the device of Figure 1 in its rest position;
  • Figure 3 is a cross-sectional view similar to that of Figure 2, which illustrates the body of the device of Figure 1 in its release position.
  • FIG. 1 shows a needleless injection device 10, or needleless syringe, which comprises a U-shaped body 12 successively comprising a percussion device 14, a gas generator 16 comprising a primer 18 and a charge pyrotechnic 20, an expansion chamber 22, a reservoir 24 containing the active ingredient 26 liquid and an injection nozzle 28.
  • the injection nozzle 28 delimits three injection channels (not shown) and is screwed onto a lower free end of the body 12.
  • the percussion device 14 and the gas generator 16 constitute a first linear subset of the body 12 which extends axially along a vertical sliding axis A, and the reservoir 24 containing the active principle 26 and the injection nozzle 28 form a second linear subset of the body 12 which extends axially along a second vertical injection axis B.
  • the tank 24 is constituted by a glass tube 30 closed by an upstream piston 32 and a downstream piston 34 between which is contained the active principle 26, the pistons being made of elastically deformable material based on elastomer.
  • the reservoir 24 extends axially from a lower flange 36 which has an annular lower face 38 arranged facing the injection nozzle 28, to an upper flange 40 having an annular upper face 42.
  • a flexible cylindrical membrane 44 comprises an annular seat 46 which is interposed axially between the upper face 40 of the reservoir 24 and the outlet orifice of the expansion chamber 22, and a cylindrical body 48 which extends axially inside the tank 24, above the upstream piston 32.
  • the body 48 of the membrane 44 is designed to extend axially, under the effect of the pressure of the gas generated by the gas generator 16, to push the upstream piston 32.
  • the body 12 is enveloped by a hollow cap 50 which delimits a lower opening closed by a horizontal sole plate forming a bottom of the hood.
  • the sole 52 delimits a circular passage 54 around the injection axis B which is adapted for the passage and the sliding of the injection nozzle 28 and the downstream end of the body 12, so that the nozzle 28 comprises a lower section projecting vertically downward from the hood 50.
  • the injection device 10 is equipped with a plug 58, shown in FIG. 1, which is mounted on the body 12 removably by a bayonet-type locking means.
  • the body 12 is slidably mounted relative to the cap 50, from bottom to top along the injection axis B, between a position resting position illustrated in FIG. 2, and an injection position illustrated in FIG.
  • the displacement of the body 12 inside the cover 50 allows the triggering of the gas generator 16 which generates a pressurized gas moving the pistons 32, 34 to move the active ingredient 26 through the skin of the user, passing through the injection nozzle 28.
  • the injection device 10 comprises a compression spring 60 which is interposed axially, along the injection axis B, between the body 12 and the cover 50, to compress the user's skin tissues during the injection. the application of the nozzle 28 to the skin, the nozzle 28 being integral in displacement of the body 12.
  • the compression spring 60 is a frustoconical helical spring which extends along the injection axis B, and which comprises a plurality of turns, here four in number, which are designed to interlock axially with each other. others.
  • helical spring frustoconical shape a spring whose turns are adapted to interlock axially in each other along the central axis of the spring.
  • the compression spring 60 extends axially from a high turn 62 which is supported on an inner face 64 of the cover 50, to a low turn 66 which bears on one face upper 68 of the body 12, the high turn 62 having a diameter greater than the diameter of the low turn 66.
  • the cover 50 delimits a housing 70 which receives the high turn 62 of the spring 60, to lock in translation the upper turn 62 in a horizontal plane.
  • the upper part of the body 12 forms a boss 72 which protrudes vertically upwards along the injection axis B, from the upper face 68 of the body 12.
  • the low turn 66 of the spring 60 is mounted around the boss 72, so that the low turn 66 is locked in translation in a horizontal plane.
  • the compression spring 60 is calibrated so that the force required to drive the body 12 from its rest position to its trigger position is between five and forty five Newtons. .
  • the compression spring 60 makes it possible to reduce the vertical space between the body 12 and the inner face 64 of the cover 50 to a coil thickness of the spring 60, when the body 12 occupies its triggering position, as can be see it in Figure 3.
  • the spring 60 makes it possible to vary the setting of the spring by acting on the section of the wire forming the turns, without substantially reducing the release path of the body 12.
  • the spring 60 due to its frustoconical shape and its turns which fit together without axial play, the addition of turns does not impact the trigger stroke.
  • turns of the spring 60 are not in contact with each other during the sliding of the body 12, so that the spring 60 emits no friction noise.
  • the larger diameter of the high turn 62 of the spring 60 allows a better stability of the spring 60.

Abstract

The invention relates to a needleless injector (10) comprising a cap (50), an injection system, a body (12) mounted so as to slide upwards in relation to the cap (50) along an injection axis (B) between a rest position and an injection position, a compression spring (60) axially intercalated along the injection axis (B) between the body (12) and the cap (50) to compress the skin tissue of the user when the nozzle (28) is applied to the skin, characterised in that the compression spring (60) is a frustroconical helical spring which extends along the injection axis (B) and comprises a plurality of turns designed to nest axially the ones inside the others.

Description

Dispositif d'injection sans aiguille équipé d'un ressort de compression  Needle-free injection device equipped with a compression spring
L'invention concerne un dispositif d'injection sans aiguille qui est équipé d'un ressort de compression. The invention relates to a needleless injection device which is equipped with a compression spring.
Le domaine technique de l'invention est celui des dispositifs d'injection sans aiguille, pré-remplis et jetables, fonctionnant avec une source d'énergie comme par exemple un générateur de gaz, et utilisés pour les injections intradermiques, sous-cutanées et intramusculaires, de principe actif liquide à usage thérapeutique en médecine humaine ou vétérinaire.  The technical field of the invention is that of needle-free injection devices, pre-filled and disposable, operating with a source of energy such as a gas generator, and used for intradermal, subcutaneous and intramuscular injections. , of liquid active ingredient for therapeutic use in human or veterinary medicine.
Le principe actif est constitué par un liquide plus ou moins visqueux, un mélange de liquide, ou un gel. Le principe actif peut également être un solide mis en solution dans un solvant approprié pour l'injection ou être constitué d'un solide pulvérulent mis en suspension à une certaine concentration dans un liquide approprié. La granulométrie du principe actif doit alors être compatible avec le diamètre des conduits pour éviter de les obturer.  The active ingredient consists of a more or less viscous liquid, a mixture of liquid, or a gel. The active ingredient may also be a solid dissolved in a solvent suitable for injection or consist of a powdery solid suspended at a certain concentration in a suitable liquid. The granulometry of the active ingredient must then be compatible with the diameter of the ducts to avoid closing them.
Un dispositif d'injection comporte de manière connue, comme par exemple dans la demande de brevet FR-A-2815544 (équivalente à WO 02/34317), un corps comprenant successivement un générateur de gaz, une chambre d'expansion, un réservoir contenant le principe actif liquide et un système d'injection.  An injection device comprises in known manner, as for example in the patent application FR-A-2815544 (equivalent to WO 02/34317), a body successively comprising a gas generator, an expansion chamber, a reservoir containing the liquid active ingredient and an injection system.
Le réservoir est constitué par un tube en verre qui est inséré dans un logement tubulaire délimité par le corps du dispositif, et qui est obturé par un piston amont et un piston aval entre lesquels est contenu le principe actif liquide.  The reservoir is constituted by a glass tube which is inserted into a tubular housing delimited by the body of the device, and which is closed off by an upstream piston and a downstream piston between which is contained the liquid active principle.
L'extrémité libre aval, ou inférieure, du réservoir, coopère avec une buse d'injection qui délimite au moins un canal d'injection s'étendant axialement suivant un axe d'injection.  The free end downstream, or lower, of the reservoir, cooperates with an injection nozzle which defines at least one injection channel extending axially along an injection axis.
La buse d'injection est délimitée axialement par une face supérieure en appui axial sur le réservoir, et une face inférieure d'injection adaptée pour coopérer avec un opercule de fermeture.  The injection nozzle is delimited axially by an upper face bearing axially on the reservoir, and a lower injection face adapted to cooperate with a closure cap.
De plus, le dispositif d'injection comporte un capot creux qui enveloppe le corps et qui délimite une ouverture inférieure adaptée pour le passage de la buse d'injection.  In addition, the injection device comprises a hollow cap which envelops the body and which delimits a lower opening adapted for the passage of the injection nozzle.
Pour permettre l'injection du principe actif, le corps est monté coulissant dans le capot, de bas en haut suivant un axe de coulissement, entre une position de repos et une position d'injection, l'entraînement du corps étant réalisé lorsque l'utilisateur appuie la buse d'injection sur sa peau. To enable the injection of the active ingredient, the body is slidably mounted in the hood, from bottom to top along a sliding axis, between a rest position and an injection position, the driving of the body being performed when the user presses the injection nozzle on his skin.
Le déplacement du corps dans le capot permet le déclenchement du générateur de gaz, générant un gaz sous pression qui entraîne en déplacement les pistons pour injecter le principe actif à travers la peau de l'utilisateur, en passant par la buse d'injection.  The movement of the body in the hood allows the triggering of the gas generator, generating a pressurized gas which drives the pistons in motion to inject the active ingredient through the skin of the user, through the injection nozzle.
Comme on peut le voir dans le document FR-A-2815544, un ressort de compression hélicoïdal est interposé axialement, suivant l'axe de coulissement, entre le corps et le capot, pour comprimer les tissus de la peau de l'utilisateur au cours de l'application de la buse sur la peau.  As can be seen in the document FR-A-2815544, a helical compression spring is interposed axially, along the axis of sliding, between the body and the cover, to compress the skin tissue of the user during the application of the nozzle on the skin.
Le dispositif de percussion est déclenché lorsque le corps atteint sa position d'injection. A cet effet, l'utilisateur doit appuyer sur le capot du dispositif d'injection, pour faire coulisser le capot par rapport au corps du dispositif suivant une course de déclenchement déterminée.  The percussion device is triggered when the body reaches its injection position. For this purpose, the user must press the hood of the injection device, to slide the cover relative to the body of the device according to a determined release stroke.
Selon ce document FR-A-2815544, la course de déclenchement est donnée par la somme des espaces entre les spires du ressort. Pour augmenter cette course il faut augmenter cet espace et donc augmenter la hauteur total du dispositif.  According to this document FR-A-2815544, the tripping stroke is given by the sum of the spaces between the turns of the spring. To increase this race you have to increase this space and therefore increase the total height of the device.
De plus, pour augmenter l'effort de compression, il est nécessaire d'augmenter le diamètre de fil du ressort ou d'ajouter des spires, ce qui augemente la hauteur total du dispositif, notamment la hauteur du capot.  In addition, to increase the compression force, it is necessary to increase the spring wire diameter or to add turns, which increases the total height of the device, including the height of the hood.
La présente invention vise notamment à résoudre ces inconvénients et se rapporte pour ce faire à un dispositif d'injection sans aiguille comportant :  The present invention aims in particular to solve these disadvantages and relates for this purpose to a needleless injection device comprising:
- un capot,  - a cap,
- un système d'injection qui comprend au moins un piston, un réservoir de principe actif, une buse d'injection délimitant au moins un canal d'injection,  an injection system comprising at least one piston, a reservoir of active principle, an injection nozzle delimiting at least one injection channel,
- un corps qui est enveloppé par le capot et qui est monté coulissant par rapport au capot, de bas en haut suivant un axe d'injection, entre une position de repos et une position d'injection,  a body which is enveloped by the hood and which is slidably mounted relative to the hood, from bottom to top along an injection axis, between a rest position and an injection position,
- un ressort de compression qui est interposé axialement, suivant l'axe d'injection, entre le corps et le capot, pour comprimer les tissus de la peau de l'utilisateur au cours de l'application de la buse sur la peau,  a compression spring which is interposed axially, along the axis of injection, between the body and the cover, to compress the tissues of the skin of the user during the application of the nozzle to the skin,
- un générateur de gaz, - un dispositif de percussion qui est conçu pour percuter le générateur de gaz, caractérisé en ce que le ressort de compression est un ressort hélicoïdal de forme tronconique qui s'étend suivant l'axe d'injection, et qui comporte une pluralité de spires conçues pour s'imbriquer axialement les unes dans les autres. - a gas generator, - A percussion device which is designed to strike the gas generator, characterized in that the compression spring is a frustoconical helical spring which extends along the injection axis, and which comprises a plurality of turns designed to interlock axially into each other.
Ainsi, le ressort de compression selon l'invention permet de réduire l'espace vertical entre le corps et la face interne du capot à une épaisseur de spire du ressort, lorsque le corps occupe sa position de déclenchement.  Thus, the compression spring according to the invention makes it possible to reduce the vertical space between the body and the internal face of the cover to a coil thickness of the spring, when the body occupies its triggering position.
De plus, le ressort de compression permet de faire varier le tarage du ressort en jouant sur la section du fil formant les spires, sans diminuer sensiblement la course de déclanchement du corps.  In addition, the compression spring makes it possible to vary the setting of the spring by acting on the section of the wire forming the turns, without substantially reducing the release path of the body.
En outre, le ressort, de par sa forme tronconique et ses spires qui s'emboîtent sans jeu axial, l'ajout de spires n'impacte pas la course de déclenchement du corps.  In addition, the spring, due to its frustoconical shape and its turns which fit together without axial play, the addition of turns does not impact the trigger stroke of the body.
Aussi, les spires du ressort ne sont pas en contact entre elles au cours du coulissement du corps, de sorte que le ressort n'émet pas de bruit de frottement.  Also, the turns of the spring are not in contact with each other during the sliding of the body, so that the spring does not emit friction noise.
Selon une autre caractéristique, le ressort de compression s'étend axialement depuis une spire haute qui est en appui sur le capot, jusqu'à une spire basse qui est en appui sur le corps, la spire haute présentant un diamètre supérieur au diamètre de la spire basse. According to another characteristic, the compression spring extends axially from a high turn which is supported on the hood, to a low turn which bears on the body, the high turn having a diameter greater than the diameter of the low spire.
Le diamètre plus important de la spire haute du ressort permet une meilleure stabilité du ressort.  The larger diameter of the upper turn of the spring allows better stability of the spring.
Selon une autre caractéristique, le capot délimite un logement qui reçoit la spire haute du ressort, pour bloquer en translation la spire haute latéralement.  According to another characteristic, the cap delimits a housing which receives the high turn of the spring, to lock in translation the high turn laterally.
Cette caractéristique permet également une meilleure stabilité du ressort.  This feature also allows for better stability of the spring.
De plus, le corps forme un bossage qui fait saillie verticalement vers le haut suivant l'axe d'injection, la spire basse du ressort étant montée autour du bossage, de sorte que la spire basse est bloquée latéralement.  In addition, the body forms a boss that protrudes vertically upward along the injection axis, the lower coil of the spring being mounted around the boss, so that the low turn is blocked laterally.
Selon un mode de réalisation préféré, le ressort de compression est taré de façon à ce que l'effort nécessaire pour entraîner le corps depuis sa position de repos, jusqu'à sa position de déclenchement, est compris entre cinq et quarante cinq Newtons. Enfin, le principe actif contenu dans le réservoir est choisi parmi le groupe comprenant les principes actifs suivants : According to a preferred embodiment, the compression spring is calibrated so that the force required to drive the body from its rest position to its trigger position is between five and forty five Newtons. Finally, the active ingredient contained in the reservoir is chosen from the group comprising the following active ingredients:
- Methotrexate,  - Methotrexate,
- Adrénaline,  - Adrenaline,
- Sumatriptan,  - Sumatriptan,
- Hydrocortisone,  - Hydrocortisone,
- Naloxone,  - Naloxone,
- Midazolam,  - Midazolam,
- Apomorphine,  - Apomorphine,
- Ethylnatrexone bromide,  - Ethylnatrexone bromide,
- Phytomenadione,  - Phytomenadione,
- Chlorpromazine hydrocloride,  - chlorpromazine hydrocloride,
- Zuclopenthixol acétate,  - Zuclopenthixol acetate,
- Danaparoid sodium,  - Danaparoid sodium,
- Enoxaparin sodium,  - Enoxaparin sodium,
- Estradiol cypionate,  Estradiol cypionate,
- Medoxyprogesterone acétate,  - Medoxyprogesterone acetate,
- Medroparin calcium,  - Medroparin calcium,
- Methylprednisolone acétate  - Methylprednisolone acetate
- Heparin calcium,  - Heparin calcium,
- Terbuline.  - Terbulin.
D'autres caractéristiques et avantages de l'invention apparaîtront à la lecture de la description détaillée qui suit pour la compréhension de laquelle on se reportera aux dessins annexés dans lesquels :  Other features and advantages of the invention will appear on reading the detailed description which follows for the understanding of which reference will be made to the appended drawings in which:
- la figure 1 est une vue en perspective éclatée axialement, qui illustre un dispositif d'injection sans aiguille, selon l'invention ;  - Figure 1 is an axially exploded perspective view, which illustrates a needleless injection device according to the invention;
- la figure 2 est une vue simplifiée en section transversale, qui illustre le corps du dispositif de la figure 1 dans sa position de repos ;  - Figure 2 is a simplified cross-sectional view, which illustrates the body of the device of Figure 1 in its rest position;
- la figure 3 est une vue en section transversale similaire à celle de la figure 2, qui illustre le corps du dispositif de la figure 1 dans sa position de déclenchement.  - Figure 3 is a cross-sectional view similar to that of Figure 2, which illustrates the body of the device of Figure 1 in its release position.
Dans la description et les revendications, pour clarifier la description et les revendications, on adoptera à titre non limitatif la terminologie longitudinal, vertical et transversal en référence au trièdre L, V, T indiqué aux figures. De plus, dans la présente demande, les termes « supérieur », « inférieur », « horizontal », « vertical », et leurs dérivés font référence à la position ou à l'orientation d'un élément ou d'un composant, cette position ou cette orientation étant considérée en référence à l'orientation du dispositif sur les figures et au trièdre L, V, T, sans référence à la gravité terrestre. In the description and the claims, to clarify the description and the claims, the longitudinal, vertical and transverse terminology will be adopted in a nonlimiting manner with reference to the L, V, T trihedron indicated in the figures. In addition, in the present application, the terms "upper", "lower", "horizontal", "vertical", and their derivatives refer to the position or orientation of an element or component, this position or this orientation being considered with reference to the orientation of the device in the figures and to the trihedron L, V, T, without reference to earth's gravity.
On a représenté à la figure 1 un dispositif 10 d'injection sans aiguille, ou seringue sans aiguille, qui comporte un corps 12 en forme de U comprenant successivement un dispositif de percussion 14, un générateur de gaz 16 comprenant une amorce 18 et une charge pyrotechnique 20, une chambre d'expansion 22, un réservoir 24 contenant le principe actif 26 liquide et une buse 28 d'injection.  FIG. 1 shows a needleless injection device 10, or needleless syringe, which comprises a U-shaped body 12 successively comprising a percussion device 14, a gas generator 16 comprising a primer 18 and a charge pyrotechnic 20, an expansion chamber 22, a reservoir 24 containing the active ingredient 26 liquid and an injection nozzle 28.
La buse 28 d'injection délimite trois canaux d'injection (non représentés) et est vissée sur une extrémité libre inférieure du corps 12.  The injection nozzle 28 delimits three injection channels (not shown) and is screwed onto a lower free end of the body 12.
Le dispositif de percussion 14 et le générateur de gaz 16 constituent un premier sous-ensemble linéaire du corps 12 qui s'étend axialement suivant un axe A de coulissement vertical, et le réservoir 24 contenant le principe actif 26 et la buse 28 d'injection forment un deuxième sous-ensemble linéaire du corps 12 qui s'étend axialement suivant un second axe B d'injection vertical.  The percussion device 14 and the gas generator 16 constitute a first linear subset of the body 12 which extends axially along a vertical sliding axis A, and the reservoir 24 containing the active principle 26 and the injection nozzle 28 form a second linear subset of the body 12 which extends axially along a second vertical injection axis B.
Ces deux sous-ensembles sont reliés l'un à l'autre par la chambre d'expansion 22 qui a un axe perpendiculaire aux axes A, B des sous- ensembles.  These two subassemblies are connected to each other by the expansion chamber 22 which has an axis perpendicular to the axes A, B of the subassemblies.
Le réservoir 24 est constitué par un tube 30 en verre obturé par un piston amont 32 et un piston aval 34 entre lesquels est contenu le principe actif 26, les pistons étant réalisés en matériau déformable élastiquement à base d'élastomère.  The tank 24 is constituted by a glass tube 30 closed by an upstream piston 32 and a downstream piston 34 between which is contained the active principle 26, the pistons being made of elastically deformable material based on elastomer.
Le réservoir 24 s'étend axialement depuis une collerette inférieure 36 qui présente une face inférieure 38 annulaire agencée en regard de la buse 28 d'injection, jusqu'à une collerette supérieure 40 présentant une face supérieure 42 annulaire.  The reservoir 24 extends axially from a lower flange 36 which has an annular lower face 38 arranged facing the injection nozzle 28, to an upper flange 40 having an annular upper face 42.
Aussi, selon la figure 1 , une membrane 44 souple cylindrique comporte un siège annulaire 46 qui est interposé axialement entre la face supérieure 40 du réservoir 24 et l'orifice de sortie de la chambre d'expansion 22, et un corps 48 cylindrique qui s'étend axialement à l'intérieur du réservoir 24, au dessus du piston amont 32. Le corps 48 de la membrane 44 est conçu pour s'étendre axialement, sous l'effet de la pression du gaz généré par le générateur de gaz 16, pour pousser le piston amont 32. Also, according to FIG. 1, a flexible cylindrical membrane 44 comprises an annular seat 46 which is interposed axially between the upper face 40 of the reservoir 24 and the outlet orifice of the expansion chamber 22, and a cylindrical body 48 which extends axially inside the tank 24, above the upstream piston 32. The body 48 of the membrane 44 is designed to extend axially, under the effect of the pressure of the gas generated by the gas generator 16, to push the upstream piston 32.
En référence à la figure 1 , le corps 12 est enveloppé par un capot 50 creux qui délimite une ouverture inférieure fermée par une semelle 52 horizontale formant fond de capot.  With reference to FIG. 1, the body 12 is enveloped by a hollow cap 50 which delimits a lower opening closed by a horizontal sole plate forming a bottom of the hood.
La semelle 52 délimite un passage circulaire 54 autour de l'axe B d'injection qui est adapté pour le passage et le coulissement de la buse 28 d'injection et de l'extrémité aval du corps 12, de sorte que la buse 28 comporte un tronçon inférieur faisant saillie verticalement vers le bas hors du capot 50.  The sole 52 delimits a circular passage 54 around the injection axis B which is adapted for the passage and the sliding of the injection nozzle 28 and the downstream end of the body 12, so that the nozzle 28 comprises a lower section projecting vertically downward from the hood 50.
Aussi, le dispositif 10 d'injection est équipé d'un bouchon 58, représenté sur la figure 1 , qui est monté sur le corps 12 de façon amovible par un moyen de verrouillage du type à baïonnette.  Also, the injection device 10 is equipped with a plug 58, shown in FIG. 1, which is mounted on the body 12 removably by a bayonet-type locking means.
Comme on peut le voir aux figures 2 et 3, sur lesquelles le bouchon 58 n'est pas représenté, le corps 12 est monté coulissant par rapport au capot 50, de bas en haut suivant l'axe B d'injection, entre une position de repos illustrée à la figure 2, et une position d'injection illustrée à la figure 3.  As can be seen in Figures 2 and 3, on which the cap 58 is not shown, the body 12 is slidably mounted relative to the cap 50, from bottom to top along the injection axis B, between a position resting position illustrated in FIG. 2, and an injection position illustrated in FIG.
Le déplacement du corps 12 à l'intérieur du capot 50 permet le déclenchement du générateur de gaz 16 qui génère un gaz sous pression entraînant en déplacement les pistons 32, 34 pour injecter le principe actif 26 à travers la peau de l'utilisateur, en passant par la buse 28 d'injection.  The displacement of the body 12 inside the cover 50 allows the triggering of the gas generator 16 which generates a pressurized gas moving the pistons 32, 34 to move the active ingredient 26 through the skin of the user, passing through the injection nozzle 28.
Aussi, le dispositif 10 d'injection comporte un ressort 60 de compression qui est interposé axialement, suivant l'axe B d'injection, entre le corps 12 et le capot 50, pour comprimer les tissus de la peau de l'utilisateur au cours de l'application de la buse 28 sur la peau, la buse 28 étant solidaire en déplacement du corps 12.  Also, the injection device 10 comprises a compression spring 60 which is interposed axially, along the injection axis B, between the body 12 and the cover 50, to compress the user's skin tissues during the injection. the application of the nozzle 28 to the skin, the nozzle 28 being integral in displacement of the body 12.
Le ressort 60 de compression est un ressort hélicoïdal de forme tronconique qui s'étend suivant l'axe B d'injection, et qui comporte une pluralité de spires, ici au nombre de quatre, qui sont conçues pour s'imbriquer axialement les unes dans les autres.  The compression spring 60 is a frustoconical helical spring which extends along the injection axis B, and which comprises a plurality of turns, here four in number, which are designed to interlock axially with each other. others.
On entend par « ressort hélicoïdal de forme tronconique » un ressort dont les spires sont adaptées pour s'imbriquées axialement les unes dans les autres suivant l'axe central du ressort.  The term "helical spring frustoconical shape" a spring whose turns are adapted to interlock axially in each other along the central axis of the spring.
Plus particulièrement, le ressort 60 de compression s'étend axialement depuis une spire haute 62 qui est en appui sur une face interne 64 du capot 50, jusqu'à une spire basse 66 qui est en appui sur une face supérieure 68 du corps 12, la spire haute 62 présentant un diamètre supérieur au diamètre de la spire basse 66. More particularly, the compression spring 60 extends axially from a high turn 62 which is supported on an inner face 64 of the cover 50, to a low turn 66 which bears on one face upper 68 of the body 12, the high turn 62 having a diameter greater than the diameter of the low turn 66.
Le capot 50 délimite un logement 70 qui reçoit la spire haute 62 du ressort 60, pour bloquer en translation la spire haute 62 dans un plan horizontal.  The cover 50 delimits a housing 70 which receives the high turn 62 of the spring 60, to lock in translation the upper turn 62 in a horizontal plane.
De plus, la partie supérieure du corps 12 forme un bossage 72 qui fait saillie verticalement vers le haut suivant l'axe B d'injection, depuis la face supérieure 68 du corps 12.  In addition, the upper part of the body 12 forms a boss 72 which protrudes vertically upwards along the injection axis B, from the upper face 68 of the body 12.
La spire basse 66 du ressort 60 est montée autour du bossage 72, de sorte que la spire basse 66 est bloquée en translation dans un plan horizontal.  The low turn 66 of the spring 60 is mounted around the boss 72, so that the low turn 66 is locked in translation in a horizontal plane.
Suivant un exemple de réalisation préféré, le ressort 60 de compression est taré de façon à ce que l'effort nécessaire pour entraîner le corps 12 depuis sa position de repos, jusqu'à sa position de déclenchement, est compris entre cinq et quarante cinq Newtons.  According to a preferred embodiment, the compression spring 60 is calibrated so that the force required to drive the body 12 from its rest position to its trigger position is between five and forty five Newtons. .
Le ressort 60 de compression selon l'invention permet de réduire l'espace vertical entre le corps 12 et la face interne 64 du capot 50 à une épaisseur de spire du ressort 60, lorsque le corps 12 occupe sa position de déclenchement, comme on peut le voir à la figure 3.  The compression spring 60 according to the invention makes it possible to reduce the vertical space between the body 12 and the inner face 64 of the cover 50 to a coil thickness of the spring 60, when the body 12 occupies its triggering position, as can be see it in Figure 3.
Ainsi, le ressort 60 permet de faire varier le tarage du ressort en jouant sur la section du fil formant les spires, sans diminuer sensiblement la course de déclanchement du corps 12.  Thus, the spring 60 makes it possible to vary the setting of the spring by acting on the section of the wire forming the turns, without substantially reducing the release path of the body 12.
De plus, le ressort 60, de par sa forme tronconique et ses spires qui s'emboîtent sans jeu axial, l'ajout de spires n'impacte pas la course de déclenchement.  In addition, the spring 60, due to its frustoconical shape and its turns which fit together without axial play, the addition of turns does not impact the trigger stroke.
Aussi, les spires du ressort 60 ne sont pas en contact entre elles au cours du coulissement du corps 12, de sorte que le ressort 60 n'émet pas de bruit de frottement.  Also, the turns of the spring 60 are not in contact with each other during the sliding of the body 12, so that the spring 60 emits no friction noise.
En outre, le diamètre plus important de la spire haute 62 du ressort 60 permet une meilleure stabilité du ressort 60.  In addition, the larger diameter of the high turn 62 of the spring 60 allows a better stability of the spring 60.

Claims

REVENDICATIONS
1 . Dispositif (10) d'injection sans aiguille comportant : 1. Needle-free injection device (10) comprising:
- un capot (50),  a cover (50),
- un système d'injection qui comprend au moins un piston (32, 34), un réservoir (24) qui contient un principe actif (26), une buse (28) d'injection délimitant au moins un canal d'injection,  an injection system which comprises at least one piston (32, 34), a reservoir (24) which contains an active principle (26), an injection nozzle (28) delimiting at least one injection channel,
- un corps (12) qui est enveloppé par le capot (50) et qui est monté coulissant par rapport au capot (50), de bas en haut suivant un axe (B) d'injection, entre une position de repos et une position d'injection,  - a body (12) which is enveloped by the cover (50) and which is slidably mounted relative to the cover (50), from bottom to top along an axis (B) of injection, between a rest position and a position injection,
- un ressort (60) de compression qui est interposé axialement, suivant l'axe (B) d'injection, entre le corps (12) et le capot (50), pour comprimer les tissus de la peau de l'utilisateur au cours de l'application de la buse (28) sur la peau,  - a compression spring (60) which is interposed axially, along the axis (B) of injection, between the body (12) and the cover (50), for compressing the skin tissue of the user during applying the nozzle (28) to the skin,
- un générateur de gaz (16),  a gas generator (16),
- un dispositif (14) de percussion qui est conçu pour percuter le générateur de gaz (16),  a percussion device (14) which is designed to strike the gas generator (16),
caractérisé en ce que le ressort (60) de compression est un ressort hélicoïdal de forme tronconique qui s'étend suivant l'axe (B) d'injection, et qui comporte une pluralité de spires conçues pour s'imbriquer axialement les unes dans les autres.  characterized in that the compression spring (60) is a frustoconical helical spring which extends along the injection axis (B), and which has a plurality of turns designed to interlock axially with each other. other.
2. Dispositif (10) d'injection sans aiguille selon la revendication 1 , caractérisé en ce que le ressort (60) de compression s'étend axialement depuis une spire haute (62) qui est en appui sur le capot (50), jusqu'à une spire basse (66) qui est en appui sur le corps (12), la spire haute (62) présentant un diamètre supérieur au diamètre de la spire basse (66).  2. Device (10) needleless injection according to claim 1, characterized in that the compression spring (60) extends axially from a high turn (62) which is supported on the cover (50), until a low turn (66) which bears on the body (12), the upper turn (62) having a diameter greater than the diameter of the low turn (66).
3. Dispositif (10) d'injection sans aiguille selon la revendication 2, caractérisé en ce que le capot (50) délimite un logement (70) qui reçoit la spire haute (62) du ressort (60), pour bloquer en translation la spire haute (62) latéralement.  3. Device (10) injection without needle according to claim 2, characterized in that the cover (50) defines a housing (70) which receives the high turn (62) of the spring (60), to lock in translation the high spire (62) laterally.
4. Dispositif (10) d'injection sans aiguille selon la revendication 2, caractérisé en ce que le corps (12) forme un bossage (72) qui fait saillie verticalement vers le haut suivant l'axe B d'injection, la spire basse (66) du ressort (60) étant montée autour du bossage (72), de sorte que la spire basse (66) est bloquée latéralement. 4. Needle-free injection device (10) according to claim 2, characterized in that the body (12) forms a boss (72) which protrudes vertically upwards along the injection axis B, the low turn (66) spring (60) being mounted around the boss (72), so that the bottom coil (66) is laterally locked.
5. Dispositif (10) d'injection sans aiguille selon l'une quelconque des revendications précédentes, caractérisé en ce que le ressort (60) de compression est taré de façon à ce que l'effort nécessaire pour entraîner le corps (12) depuis sa position de repos, jusqu'à sa position de déclenchement, est compris entre cinq et quarante cinq Newtons. Needle-free injection device (10) according to one of the preceding claims, characterized in that the compression spring (60) is calibrated so that the force required to drive the body (12) from its rest position, up to its trigger position, is between five and forty five Newtons.
6. Dispositif (10) d'injection sans aiguille selon l'une quelconque des revendications précédentes, caractérisé en ce que le principe actif (26) contenu dans le réservoir (24) est choisi parmi le groupe comprenant les principes actifs suivants :  6. Device (10) needleless injection according to any one of the preceding claims, characterized in that the active ingredient (26) contained in the reservoir (24) is selected from the group consisting of the following active ingredients:
- Methotrexate,  - Methotrexate,
- Adrénaline,  - Adrenaline,
- Sumatriptan,  - Sumatriptan,
- Hydrocortisone,  - Hydrocortisone,
- Naloxone,  - Naloxone,
- Midazolam,  - Midazolam,
- Apomorphine,  - Apomorphine,
- Ethylnatrexone bromide,  - Ethylnatrexone bromide,
- Phytomenadione,  - Phytomenadione,
- Chlorpromazine hydrocloride,  - chlorpromazine hydrocloride,
- Zuclopenthixol acétate,  - Zuclopenthixol acetate,
- Danaparoid sodium,  - Danaparoid sodium,
- Enoxaparin sodium,  - Enoxaparin sodium,
- Estradiol cypionate,  Estradiol cypionate,
- Medoxyprogesterone acétate,  - Medoxyprogesterone acetate,
- Medroparin calcium,  - Medroparin calcium,
- Methylprednisolone acétate  - Methylprednisolone acetate
- Heparin calcium,  - Heparin calcium,
- Terbuline.  - Terbulin.
PCT/FR2016/051656 2015-06-30 2016-06-30 Needleless injector with a compression spring WO2017001795A1 (en)

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EP16742361.5A EP3316932B1 (en) 2015-06-30 2016-06-30 Needleless injector with a compression spring
ES16742361T ES2735424T3 (en) 2015-06-30 2016-06-30 Needleless injection device equipped with a compression spring
US15/848,043 US20180110929A1 (en) 2015-06-30 2017-12-20 Needleless injection device equipped with a compression spring

Applications Claiming Priority (2)

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FR15/56165 2015-06-30
FR1556165A FR3038232B1 (en) 2015-06-30 2015-06-30 INJECTION DEVICE WITHOUT NEEDLE EQUIPPED WITH A COMPRESSION SPRING

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FR3067246B1 (en) 2017-06-09 2019-08-09 Crossject PLATE FOR MAINTAINING DRUG INJECTION DEVICE TUBES
AU2019283460A1 (en) * 2018-06-06 2020-11-19 Datamars Limited Improvements in, or relating to, applicators
FR3087116A1 (en) 2018-10-10 2020-04-17 Crossject DEVICE FOR HOLDING TUBES OF INJECTION DEVICE

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EP2937111B1 (en) * 2012-12-21 2020-03-18 Hisamitsu Pharmaceutical Co., Inc. Applicator

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WO1997021457A1 (en) * 1995-12-11 1997-06-19 Elan Medical Technologies Limited Cartridge-based drug delivery device
FR2815544A1 (en) 2000-10-23 2002-04-26 Poudres & Explosifs Ste Nale Needle-less syringe with gas generator to expel active substance has compact body with gas generator actuated by sliding cap
WO2002034317A1 (en) 2000-10-23 2002-05-02 Crossject Compact architecture needleless syringe
US20140060263A1 (en) * 2012-08-30 2014-03-06 Tsang-Hai Lin Fitting assembly for hand tool

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ES2735424T3 (en) 2019-12-18
US20180110929A1 (en) 2018-04-26
EP3316932B1 (en) 2019-04-24
EP3316932A1 (en) 2018-05-09
FR3038232B1 (en) 2017-07-28

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